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Blue Rhino G2-Multi
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref C-PTIS-100-HC-G-EU-EVAC7.5
by Cook Ireland
Identity
- Trade Name
- Blue Rhino G2-Multi EUDAMEDBlue Rhino FDA UDI
- Generic Name
- Tracheostomy kit, single-use FDA UDI
- Device Name
- Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set EUDAMEDFDA UDI
- Model / Reference
- C-PTIS-100-HC-G-EU-EVAC7.5 EUDAMEDG57697 FDA UDI
- Description
- Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set FDA UDI
Identifiers
- Catalog Number
- C-PTIS-100-HC-G-EU-EVAC7.5 FDA UDI
- Primary DI / UDI-DI
- 00827002576971 EUDAMEDFDA UDI
- Basic UDI-DI
- 0827002CIRL202203071034CJ EUDAMED
- 510(k) Number
- K193133 FDA UDI
- FDA Product Code
- JOH FDA UDI
- EMDN Code
- R010601 CIAGLIA TRACHEOSTOMY KITS EUDAMED
- GMDN Term
- Tracheostomy kit, single-use FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5800 FDA UDI
- Medical Purpose
- The Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set is used to provide mutually compatible medical devices for percutaneous dilatational tracheostomy procedure. EUDAMED
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Blue Rhino G2-Multi by Cook Ireland — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0827002CIRL202203071034CJ | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Cook Ireland
- EUDAMED SRN
- IE-PR-000002461
Sources (2)
- EUDAMED c977d232-5b21-49e9-998e-582320a302d8 61 fields · synced May 30, 2026
- FDA UDI aa4e7e9f-7ada-4374-8712-5a4a0b4508ee 38 fields · synced May 30, 2026